Field of the Disclosure
The present disclosure relates generally to hemostatic devices, and more particularly, to hemostatic devices based on non-oxidized regenerated cellulose.
Background Information
In the treatment of moderate to severe traumas, controlling bleeding is essential and critical to minimize blood loss. The process of healing injuries begins with the adhesion and agglutination of platelets to injured tissue, and the simultaneous liberation of thromboplastin from injured cells. To aid in this process, hemostatic wound dressings are used for sealing an injured site, thereby reducing the loss of blood, activating the clotting mechanisms and promoting hemostasis.
Conventional hemostatic wound dressings include knitted or non-woven fabrics comprising carboxylic-oxidized cellulose. Typically, oxidized cellulose is implemented as carboxylic-oxidized regenerated cellulose comprising reactive carboxylic acid groups which have been treated to increase the homogeneity of the cellulose fiber.
Due to its biodegradability and its bactericidal and hemostatic properties, oxidized cellulose that has been modified to contain carboxylic acid moieties has long been used as a topical hemostatic wound dressing in a variety of bleeding traumas, such as, wounds, internal organ traumas, and surgical procedures.
While the absorbency of body fluids and the hemostatic action of currently available carboxylic-oxidized cellulose hemostats are adequate for applications where mild to moderate bleeding is encountered, they are not known to be effective for providing and maintaining hemostasis in cases of severe bleeding, and non-compressional or non-tourniquetable wounds. Examples of severe bleeding and non-compressional or non-tourniquetable wounds include arterial puncture, liver resection, blunt liver trauma, blunt spleen trauma, aortic aneurysm, etc., where a relatively high volume of blood is lost at a relatively high rate. In such instances, a higher degree of hemostasis is required and the improved hemostasis needs to be implemented over a shorter period of time. Additionally, there is no clinical data that oxidized carboxymethyl cellulose (CMC) is effective in patients with coagulopathies.